Novartis’ Kisqali combo boosts survival in HR+/HER2- advanced breast cancer

pharmafile | June 3, 2019 | News story | Research and Development, Sales and Marketing Cancer, Kisqali, Novartis, breast cancer, pharma 

Novartis took the opportunity at this year’s American Society of Clinical Oncology (ASCO) Annual Meeting to reveal new Phase 3 data on Kisqali (ribociclib) in combination with endocrine therapy (either an aromatase inhibitor or tamoxifen) in the initial treatment of hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer in pre- and perimenopausal women.

The findings, taken from 672 premenopausal, HR+ or HER2- breast cancer patients under 59, revealed that the Kisqali combo improved overall survival rates by 70.2% in the intent-to-treat population after 42 months, compared to 46% with endocrine therapy.

The data presented was collated after the study was stopped early due to meeting its efficacy criteria, prompting an interim analysis after 192 patient deaths. At the time the study was cut short, 25% of patients were continuing adhering to the Kisqali combo regimen.

Additionally, the combo reduced the risk of death by 30% compared to an aromatase inhibitor alone, while Kisqali combined with tamoxifen reduced the risk of death by 20.9% compared to tamoxifen alone.

“Overall survival benefit is considered the ‘gold standard’ in cancer trials but is challenging to achieve in HR+/HER2- metastatic breast cancer. MONALEESA-7 reached this important endpoint earlier than anticipated,” explained Dr Sara Hurvitz, Medical Director of the Jonsson Comprehensive Cancer Center Clinical Research Unit and Director of the Breast Cancer Clinical Trials Program at UCLA. “Impactful results like these ribociclib findings are what we wish for in every clinical trial, and to achieve overall survival improvement in an incurable disease, like metastatic breast cancer, is truly an outstanding advancement for patients.”

Dr Susanne Schaffert, CEO at Novartis Oncology, also remarked: “Kisqali is the only CDK4/6 inhibitor to achieve statistically significant overall survival benefit in combination with endocrine therapy, and we are so proud to share these powerful data with the medical and patient community. These exciting results add to the proven efficacy and safety profile of Kisqali, solidify it as a standard of care for people living with HR+/HER2- metastatic breast cancer and inspire us to continue to reimagine medicine.”

Matt Fellows

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